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Evaluation of a new reagent strip rapid urease test for detection of Helicobacter pylori infection.

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Title: Evaluation of a new reagent strip rapid urease test for detection of Helicobacter pylori infection.
Authors: Yousfi MM; Department of Medicine, Veterans Affairs Medical Center, Houston, Texas 77030, USA., el-Zimaity HM, Genta RM, Graham DY
Source: Gastrointestinal endoscopy [Gastrointest Endosc] 1996 Nov; Vol. 44 (5), pp. 519-22.
Publication Type: Clinical Trial; Comparative Study; Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.
Language: English
Journal Info: Publisher: Mosby Yearbook Country of Publication: United States NLM ID: 0010505 Publication Model: Print Cited Medium: Print ISSN: 0016-5107 (Print) Linking ISSN: 00165107 NLM ISO Abbreviation: Gastrointest Endosc Subsets: MEDLINE
Imprint Name(s): Publication: St Louis, Mo : Mosby Yearbook
Original Publication: Denver.
MeSH Terms: Reagent Strips*, Helicobacter Infections/*microbiology , Helicobacter pylori/*isolation & purification , Urease/*analysis, Gastric Mucosa/microbiology ; Helicobacter pylori/enzymology ; Pyloric Antrum/microbiology ; Adult ; Agar ; Aged ; Aged, 80 and over ; Biopsy ; Evaluation Studies as Topic ; False Negative Reactions ; False Positive Reactions ; Female ; Gels ; Humans ; Male ; Middle Aged
Abstract: Background: Rapid urease tests are commonly used as a convenient method to detect Helicobacter pylori infection. Our previous experiments demonstrated enhanced efficacy of agar gel rapid urease test compared with reagent strip rapid urease tests. We evaluated the efficacy of PyloriTek, a new reagent strip rapid test for detecting H. pylori infection.
Methods: Gastric antral mucosal biopsy specimens were obtained for comparison between agar gel rapid urease tests and PyloriTek (200 specimens). The rapid urease test to be used first was selected randomly. H. pylori status was determined using the Genta stain. Culture was performed to confirm H. pylori status when false rapid urease tests were suspected.
Results: One hundred patients were studied; 68 had H. pylori infection. There were two false-negative and one false-positive PyloriTek when scored at 1 hour, compared with only one false-positive and no false-negative tests at 2 hours. With the agar gel rapid urease tests, there were no false-positive tests and 5 false-negative tests when scored at 1 hour, 2 false-negative tests at 12 hours and 1 at 24 hours; there were no false-positive tests. At 1 hour, 3% (95% CI = 1% to 9%) of PyloriTek tests had an erroneous categorization of H. pylori status compared with 5% for the agar gel rapid urease tests (95% CI = 1.6% to 11%) (p > 0.7).
Conclusion: The new reagent strip rapid urease test, PyloriTek, is rapid and comparable in accuracy to agar gel rapid urease tests for detecting H. pylori Infection.
Substance Nomenclature: 0 (Gels)
0 (Reagent Strips)
9002-18-0 (Agar)
EC 3.5.1.5 (Urease)
Entry Date(s): Date Created: 19961101 Date Completed: 19970304 Latest Revision: 20190722
Update Code: 20260130
DOI: 10.1016/s0016-5107(96)70001-9
PMID: 8934154
Database: MEDLINE
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  – Url: https://www.doi.org/10.1016/s0016-5107(96)70001-9?
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  Label: Title
  Group: Ti
  Data: Evaluation of a new reagent strip rapid urease test for detection of Helicobacter pylori infection.
– Name: Author
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  Group: Au
  Data: <searchLink fieldCode="AU" term="%22Yousfi+MM%22">Yousfi MM</searchLink>; Department of Medicine, Veterans Affairs Medical Center, Houston, Texas 77030, USA.<br /><searchLink fieldCode="AU" term="%22el-Zimaity+HM%22">el-Zimaity HM</searchLink><br /><searchLink fieldCode="AU" term="%22Genta+RM%22">Genta RM</searchLink><br /><searchLink fieldCode="AU" term="%22Graham+DY%22">Graham DY</searchLink>
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  Data: <searchLink fieldCode="JN" term="%220010505%22">Gastrointestinal endoscopy</searchLink> [Gastrointest Endosc] 1996 Nov; Vol. 44 (5), pp. 519-22.
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  Label: Publication Type
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  Data: Clinical Trial; Comparative Study; Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.
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  Data: English
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Mosby+Yearbook%22">Mosby Yearbook </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>0010505 <i>Publication Model: </i>Print <i>Cited Medium: </i>Print <i>ISSN: </i>0016-5107 (Print) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2200165107%22">00165107 </searchLink><i>NLM ISO Abbreviation: </i>Gastrointest Endosc <i>Subsets: </i>MEDLINE
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  Label: Imprint Name(s)
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  Data: <i>Publication</i>: St Louis, Mo : Mosby Yearbook<br /><i>Original Publication</i>: Denver.
– Name: SubjectMESH
  Label: MeSH Terms
  Group: Su
  Data: <searchLink fieldCode="MM" term="%22Reagent+Strips%22">Reagent Strips*</searchLink><br /><searchLink fieldCode="MM" term="%22Helicobacter+Infections%22">Helicobacter Infections</searchLink>/<searchLink fieldCode="MM" term="%22Helicobacter+Infections+microbiology%22">*microbiology</searchLink> <br /><searchLink fieldCode="MM" term="%22Helicobacter+pylori%22">Helicobacter pylori</searchLink>/<searchLink fieldCode="MM" term="%22Helicobacter+pylori+isolation+%26+purification%22">*isolation & purification</searchLink> <br /><searchLink fieldCode="MM" term="%22Urease%22">Urease</searchLink>/<searchLink fieldCode="MM" term="%22Urease+analysis%22">*analysis</searchLink><br /><searchLink fieldCode="MH" term="%22Gastric+Mucosa%22">Gastric Mucosa</searchLink>/<searchLink fieldCode="MH" term="%22Gastric+Mucosa+microbiology%22">microbiology</searchLink> ; <searchLink fieldCode="MH" term="%22Helicobacter+pylori%22">Helicobacter pylori</searchLink>/<searchLink fieldCode="MH" term="%22Helicobacter+pylori+enzymology%22">enzymology</searchLink> ; <searchLink fieldCode="MH" term="%22Pyloric+Antrum%22">Pyloric Antrum</searchLink>/<searchLink fieldCode="MH" term="%22Pyloric+Antrum+microbiology%22">microbiology</searchLink> ; <searchLink fieldCode="MH" term="%22Adult%22">Adult</searchLink> ; <searchLink fieldCode="MH" term="%22Agar%22">Agar</searchLink> ; <searchLink fieldCode="MH" term="%22Aged%22">Aged</searchLink> ; <searchLink fieldCode="MH" term="%22Aged%2C+80+and+over%22">Aged, 80 and over</searchLink> ; <searchLink fieldCode="MH" term="%22Biopsy%22">Biopsy</searchLink> ; <searchLink fieldCode="MH" term="%22Evaluation+Studies+as+Topic%22">Evaluation Studies as Topic</searchLink> ; <searchLink fieldCode="MH" term="%22False+Negative+Reactions%22">False Negative Reactions</searchLink> ; <searchLink fieldCode="MH" term="%22False+Positive+Reactions%22">False Positive Reactions</searchLink> ; <searchLink fieldCode="MH" term="%22Female%22">Female</searchLink> ; <searchLink fieldCode="MH" term="%22Gels%22">Gels</searchLink> ; <searchLink fieldCode="MH" term="%22Humans%22">Humans</searchLink> ; <searchLink fieldCode="MH" term="%22Male%22">Male</searchLink> ; <searchLink fieldCode="MH" term="%22Middle+Aged%22">Middle Aged</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Background: Rapid urease tests are commonly used as a convenient method to detect Helicobacter pylori infection. Our previous experiments demonstrated enhanced efficacy of agar gel rapid urease test compared with reagent strip rapid urease tests. We evaluated the efficacy of PyloriTek, a new reagent strip rapid test for detecting H. pylori infection.<br />Methods: Gastric antral mucosal biopsy specimens were obtained for comparison between agar gel rapid urease tests and PyloriTek (200 specimens). The rapid urease test to be used first was selected randomly. H. pylori status was determined using the Genta stain. Culture was performed to confirm H. pylori status when false rapid urease tests were suspected.<br />Results: One hundred patients were studied; 68 had H. pylori infection. There were two false-negative and one false-positive PyloriTek when scored at 1 hour, compared with only one false-positive and no false-negative tests at 2 hours. With the agar gel rapid urease tests, there were no false-positive tests and 5 false-negative tests when scored at 1 hour, 2 false-negative tests at 12 hours and 1 at 24 hours; there were no false-positive tests. At 1 hour, 3% (95% CI = 1% to 9%) of PyloriTek tests had an erroneous categorization of H. pylori status compared with 5% for the agar gel rapid urease tests (95% CI = 1.6% to 11%) (p > 0.7).<br />Conclusion: The new reagent strip rapid urease test, PyloriTek, is rapid and comparable in accuracy to agar gel rapid urease tests for detecting H. pylori Infection.
– Name: NumberCAS
  Label: Substance Nomenclature
  Group: ID
  Data: 0 (Gels)<br />0 (Reagent Strips)<br />9002-18-0 (Agar)<br />EC 3.5.1.5 (Urease)
– Name: DateEntry
  Label: Entry Date(s)
  Group: Date
  Data: <i>Date Created: </i>19961101 <i>Date Completed: </i>19970304 <i>Latest Revision: </i>20190722
– Name: DateUpdate
  Label: Update Code
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  Data: 20260130
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  Data: 10.1016/s0016-5107(96)70001-9
– Name: AN
  Label: PMID
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  Data: 8934154
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=cmedm&AN=8934154
RecordInfo BibRecord:
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      – Type: doi
        Value: 10.1016/s0016-5107(96)70001-9
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        StartPage: 519
    Subjects:
      – SubjectFull: Gastric Mucosa microbiology
        Type: general
      – SubjectFull: Helicobacter pylori enzymology
        Type: general
      – SubjectFull: Pyloric Antrum microbiology
        Type: general
      – SubjectFull: Adult
        Type: general
      – SubjectFull: Agar
        Type: general
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      – SubjectFull: Aged, 80 and over
        Type: general
      – SubjectFull: Biopsy
        Type: general
      – SubjectFull: Evaluation Studies as Topic
        Type: general
      – SubjectFull: False Negative Reactions
        Type: general
      – SubjectFull: False Positive Reactions
        Type: general
      – SubjectFull: Female
        Type: general
      – SubjectFull: Gels
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        Type: general
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        Type: general
      – SubjectFull: Reagent Strips
        Type: general
      – SubjectFull: Helicobacter Infections microbiology
        Type: general
      – SubjectFull: Helicobacter pylori isolation & purification
        Type: general
      – SubjectFull: Urease analysis
        Type: general
    Titles:
      – TitleFull: Evaluation of a new reagent strip rapid urease test for detection of Helicobacter pylori infection.
        Type: main
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            NameFull: Yousfi MM
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            NameFull: el-Zimaity HM
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            NameFull: Genta RM
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            – D: 01
              M: 11
              Text: 1996 Nov
              Type: published
              Y: 1996
          Identifiers:
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            – TitleFull: Gastrointestinal endoscopy
              Type: main
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